Overview
Level: Intermediate/Advanced
Type: Certificate
ISPE Continuing Education Units (CEUs): 10.9
The Biopharmaceutical Essentials certificate program is designed to provide comprehensive knowledge and practical skills in the field of biopharmaceutical drug substance manufacturing. This program is ideal for professionals seeking to deepen their understanding of biopharmaceutical processes, facility design, aseptic processing, and regulatory considerations. Through a series of expert-led training courses, participants will gain insights into the latest industry standards and practices essential for advancing their careers.
Benefits
- Current Content:
- All courses in the ISPE library are updated periodically and when there are new regulations and trends in the industry. Attendees will be kept up to date with the “C” in CGMP learning the latest in industry practice.
- Comprehensive Curriculum:
- The program covers a wide range of topics including biopharmaceutical manufacturing processes, biotechnology facility design, aseptic processing, and specific considerations for advanced therapies such as cell and gene therapies (CGT) and advanced therapy medicinal products (ATMPs).
- Expert Instructors:
- Learn from industry experts with extensive experience in biopharmaceutical development, manufacturing and regulatory compliance.
- Practical Knowledge:
- Courses are designed to provide actionable insights and practical skills that can be directly applied to your professional role.
- Networking Opportunities:
- Connect with peers and industry leaders through interactive sessions and collaborative learning environments.
- ISPE CEUs:
- Earn CEUs to demonstrate your commitment to professional development and stay current with industry standards.
Course Curriculum
Key Takeaways
- Biopharmaceutical Manufacturing Processes
- Gain a foundational understanding of biopharmaceutical manufacturing, including the key processes, technologies, and regulatory requirements that ensure the production of safe and effective biopharmaceutical products.
- Biotechnology Manufacturing Facility Design
- Explore the critical aspects of designing and operating a biotechnology manufacturing facility. This course covers layout considerations, equipment selection, and compliance with regulatory guidelines to ensure efficient and compliant operations.
- Aseptic Processing and Annex 1
- Delve into the principles and practices of aseptic processing, focusing on the latest updates to Annex 1. Learn about cleanroom design, contamination control, and validation techniques essential for maintaining aseptic conditions.
- ATMP Manufacturing
- Understand the unique challenges and regulatory landscape associated with the manufacturing of ATMPs, including cell and gene therapies. This course provides insights into the specific requirements for producing these cutting-edge therapies.
- Introduction to Biopharmaceuticals: Large Molecule Therapeutics
- This introductory course provides an overview of large molecule therapeutics, including their development, manufacturing processes, and regulatory considerations. It is designed for those new to the biopharmaceutical industry or seeking to broaden their knowledge.
- Biopharmaceuticals CMC Aspects
- Focus on the chemistry, manufacturing, and controls (CMC) aspects of biopharmaceuticals. This course covers critical topics such as formulation development, process validation, and quality control strategies.
- Biopharmaceuticals: CGT and ATMP
- Examine the specific considerations for the development and manufacturing of CGTs and ATMPs. This course addresses the unique scientific and regulatory challenges associated with these innovative treatments.
ISPE CEUs
Participants in the Biopharmaceutical Essentials certificate program will earn CEUs for each completed course. These CEUs are valuable for maintaining professional certifications and demonstrating ongoing commitment to professional growth and industry expertise.
Embark on the Biopharmaceutical Essentials certificate program to enhance your skills, expand your knowledge, and advance your career in the dynamic and evolving field of biopharmaceutical manufacturing.
Program Format
The instructor-led and on-demand courses will be presented through lectures, articles, videos, with interactive breakout sessions, polls, team activities, and exercises reflecting current pharmaceutical industry requirements.
Course Modules
- Overview Biopharmaceutical Manufacturing Processes Biotech Basics
- Regulatory and Quality by Design (QbD)
- Culture of Cells and Media
- Filtration processes
- Viral Removal and Inactivation
- Chromatography
- Single-use Technologies
- Facilities and Utilities
- Scale-up
- Biotechnology Manufacturing Facility Design
- Introduction: Biomanufacturing Design Considerations
- The Role of Quality by Design (ICH Q8) in Facility Design
- Regulatory Expectations - Designing for Compliance
- QbD in Facility Design
- Defining the Process - CQAs, CPPs, Design Space
- Equipment Considerations
- Facility Considerations
- Utility and Support Systems
- Facility Qualification, Verification, and Process Validation
- Risk Assessment
- Reference materials: ICH Q8, ICH Q9, ASTM E2500, 2011 FDA Guidance for Process Validation
- ATMP Manufacturing
- Introduction to ATMPs
- The Science behind ATMPs
- Regulatory Aspects/QRM of ATMP Manufacturing: Focus on Cell Therapies
- Supply Chain Considerations for ATMPS:Focus on Cell Therapies
- Manufacturing Considerations for ATMPs: Focus on Autologous Cell Therapies
- Facility Considerations
- Tech Transfer, Scale-up, and Supply Chain Considerations
- Aseptic Processing and Annex 1
- Introduction to the Regulatory Framework
- Hot Topics from Annex 1
- Interaction of Process and Aseptic Fill/Finish Operations
- Principles of Aseptic Processing
- Process Development and Validation
- Quality Risk Management
- Training Systems
- Interactive Session/Case-Based Learning
- How to Prepare for Regulatory Inspections
- Biopharmaceuticals: Introduction to Large Molecule Therapeutics
- Overview of the Biopharmaceutical Development Process
- Early Phase Development
- Late Phase Development
- Biopharmaceuticals: CMC Aspects
- Overview of the Biopharmaceutical Development Process
- Quality by Design (QbD)
- Cell Line and Upstream Development
- Downstream Development
- Analytical Development
- Formulation and Stability
- Drug Product
- CGMP Manufacturing Lifecycle
- Comparability and Biosimilars
- Cost of Goods: Factors and Opportunities to Control Cost of Goods
- Regulatory Acceleration: Opportunities/Options that can be Deployed to Accelerate Regulatory Approvals (Speed to Market)
- Biopharmaceuticals: CGT and ATMP
- Overview of CGT Modalities and Platforms
- Cell and Gene Therapy Market
- Definitions, Manufacturing and Analytical Characterization of CGT Products
- Plasmids
- mRNA
- Lipid Nano Particles
- Viral Vectors
- Cell Therapy
- Cost Controls
Who Should Attend
- Individuals who want to improve their working knowledge of biopharmaceutical development
- Service organizations, suppliers, and vendors who serve pharmaceutical industry Clients focused on biopharmaceutical manufacturing
- Academic institutions engaged in biopharmaceutical development/manufacturing
- Vendors and suppliers of equipment/systems focused on the global biopharmaceutical launch process
- Industry professionals focused on manufacturing risk assessment/mitigation
- Quality assurance and quality control specialists
- Validation specialists
Community of Practice (COP)
This certificate is of particular interest to:
Pricing
Ala Carte Price | Non-Member Certificate Price | Member Certificate Price | EE/Gov/Academia |
---|
$13,575.00 | $8,800.00 | $7,100.00 | $2,500.00 |
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Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.
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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View Upcoming Courses